Comparing the effects of a triple therapy and dual bronchodilators on COPD patients
Official title: The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
Run by Mahidol University · NCT06474039 · Data updated 2026-11-12
This study is testing whether a new combination treatment for COPD that includes three medications works better than a treatment with just two medications to help patients breathe easier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkoknoi, BKK) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT06474039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with COPD GOLD B who have had no more than one exacerbation in the past year and have previously received bronchodilator treatments.
✕Probably not a fit
Patients with active pulmonary diseases, malignancies, or those currently on triple therapy or immunosuppressive treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy of a combination therapy involving fluticasone furoate, vilanterol, and umeclidinium against a dual bronchodilator treatment in patients with Chronic Obstructive Pulmonary Disease (COPD). It focuses on measuring improvements in air trapping and levels of inflammatory cytokines in the blood and airways. Patients eligible for the study must have experienced limited exacerbations and have been previously treated with specific bronchodilators. The study aims to provide insights into the benefits of triple therapy compared to dual therapy in managing COPD symptoms.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for COPD patients, enhancing their lung function and reducing inflammation.
How similar studies have gone: Other studies have shown promising results with similar combination therapies in COPD management, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence. * Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators * Patients who are able to provide informed consent. Exclusion Criteria: * \- Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases. * Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids * Being treated with triple therapy (ICS/LABA/LAMA) * Being in terminally ill conditions
Where it's running
-
Division of Respiratory Disease and TB, Siriraj Hospital
Bangkoknoi, Bkk, Thailand Recruiting
Study contacts
- Principal investigator: Kittipong Maneechotesuwan, MD,PhD — Siriraj Hospital
- Study coordinator: kittipong maneechotesuwan, MD, PhD.
- Email: kittipong.man@mahidol.ac.th
- Phone: 0894996858
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer
This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.
-
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Biomarker clues for COPD, IPF, and lung cancer
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HRS-9821 Inhalation Suspension for COPD: Safety and Dose Finding in Adults
This study tests whether HRS-9821 inhalation can be safely taken and help people with moderate to severe COPD, and aims to find a reasonable dose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.